Category: Personal Sound Amplification

Personal Sound Amplification


FDA Issues Letter to “OTC Hearing Aid” Manufacturers

A letter by the FDA's William Maisel cautions that hearing devices cannot use “OTC hearing aids” in their marketing since the FDA definition of this hearing aid class—which would probably include severity of loss and other important safety, quality, and labeling requirements—has not yet been established.

Evaluating Select Personal Sound Amplifiers and a Consumer-Decision Model for OTC Amplification

OTC hearing devices are coming, but how should they function and for whom should they be recommended? Drs Ron Leavitt, Ruth Bentler, and Carol Flexer present six case studies showing that people with true moderate hearing loss may not be well served by what has been characterized as a “consumer-decides” model of care.

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Elite 2017 Business Summit Elevates Independents in Era of Disruptive Change

This year’s Summit theme was “Elevate Your Independence,” focusing on how independent hearing care professionals can succeed in an era of disruptive technology, distribution, and what may ultimately be a new regulatory environment. Included in the Summit’s General Session was a historical perspective on the current over-the-counter device proposals, as well as a review of a recent pilot study that supports professionally dispensed hearing aids over OTC.

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HIA Recommends OTC Hearing Devices Be Restricted to Mild Losses; Retain Consumer Safety and Efficacy Assurances

The Hearing Industries Association has recommended that, if the FDA creates a new over-the-counter (OTC) category for hearing devices, these products be confined to mild hearing losses and comply with the same safety and efficacy standards required for air-conduction hearing aids. Further, if the OTC category is established, HIA recommends that FDA review and finalize its guidance for PSAPs so these devices cannot be marketed to address hearing loss.

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ADA Lends Qualified Support for PCAST Recommendations

In giving qualified support to the PCAST recommendations, ADA is the first among the hearing care professional organizations to publicly endorse, at least in principle, the PCAST’s report to the president. However, ADA listed a number of important qualifications emphasizing the importance of the audiologists’ role in hearing evaluation and diagnostics, dispensing, and aural rehabilitation, as well as some necessary standards for PSAPs, entry-level devices, and hearables.

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